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Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity

NCT ID: NCT03321877

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-05-31

Brief Summary

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An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.

Detailed Description

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We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects.

This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control.

After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study group

All included patients underwent dose reduction.

Group Type EXPERIMENTAL

Change to dose of patient's regular medication

Intervention Type DRUG

Dose reduction of the drug each patient was already taking

Interventions

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Change to dose of patient's regular medication

Dose reduction of the drug each patient was already taking

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Physician-diagnosed asthma for at least 6 months
* Fulfill ERS/ATS giudelines for severe asthma
* Stable dose of ICS for at least 4 weeks
* Able to carry out study procedures
* Negative metacholine provocation test at screening
* Negative reversibility to beta agonist at screening
* FeNO under 50 ppb

Exclusion Criteria

* Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months
* FEV1 under 70% of predicted
* Acute upper or lower airway infection requiring antibiotics in the last 4 weeks
* Exacerbation of asthma requiring prednisolone in the last 6 months
* Current smoking
* Pregnancy or breastfeeding
* Other clinically significant lung disease
* Current participation in another interventional study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eileen Wedge

Research doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lungemedicinsk Forskningsenhed

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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55855

Identifier Type: -

Identifier Source: org_study_id